One of my favorites was a talk by Peter Wittner, of consulting group Interpharm, who gave a very interesting talk on the evolution of the respiratory (inhaled) generic market and the dissolving boundary between the traditional innovators and the generic manufacturers.

A recent article in the Economist – “Generically Challenged,” from the World in 2010 issue – lays out the growing interest of the major innovators in the generics drug companies, prompted in part by the “looming patent cliff.” According to EvaluatePharma, the total sales of prescription drugs at risk from patent expiry is set to more than double from 2010 to 2011. Vijay Vaitheeswaran argues that government attempts to control prices are propelling generics in high income countries, while in low income countries it is the growing middle classes. In fact, emerging economies already make up more than half of total global pharmaceutical sales.

Back in London, Wittner drew attention to the appeal of the branded generics approach. These are products made of off-patent formulations but sold for premium price. By his account, one company (Norton) was able to recognize that a lengthy generic name (sodium cromoglycate, rather than Intal) was hindering physicians from writing a prescription. In response, they adopted a branded generic approach, raised the price of their product, and labeled it Cromolyn. The Economist predicts that the major drugs firms are set to aggressively enter the branded generics market next year. It highlights a number of recent acquisitions and alliances between the big drugs firms and Asian generics firms like Ranbaxy.

Wittner also outlined the barriers facing the generics companies (such as proving bioequivalence) and some of the complicated struggles around patents in the respiratory drug market. There are several examples that illustrate how skilled generics companies have become at attacking weak patents; he discussed the recent European challenges to the Seretide and Symbicort patents in particular.

Finally, Wittner offered great bit on the lateral thinking and agility of generics companies, who are developing and protecting innovative new respiratory delivery devices and active pharmaceutical ingredients (API). He closed with some observations on the uncertainty around the potential competitors set to emerge from the Asian market and outlined some of the competitive advantages that Asian companies have, including a favorable regulatory environment.

On the airplane yesterday I read a great article from the Lancet – Medicine prices, availability, and affordability in 36 developing and middle-income countries – that I’d been carrying around for a while but never gotten to. It describes the development of a standardized method by WHO and Health Action International to routinely measure medicine prices, availability and affordability and make international comparisons. The full-text of the article and an accompanying editorial are available online for free. 

The paper presents the results of 45 surveys done in 36 countries, and notes that more than 50 surveys have now been done – with results available here. 

The article has a handful of striking statistics. For example, they report that medicines account for 20-60 percent of health spending in developing and transitional countries, compared with 18 percent in OECD countries. In addition, up to 90 percent of the populations in developing countries pay for medicines out of pocket, making, them “the largest family expenditure after food.”

In a nutshell, the project involved a multistage clustered sample of health care facilities in urban centers and outlying areas. Surveys examined a standard list of 30 core medicines that indicate a range of treatments for common acute and chronic conditions. The core medicines are “recommended, usually as first-line courses of treatment, in global, regional, and national treatment guidelines…Most are on the WHO Model List of Essential Medicines.” Up to 20 supplemental locally-relevant medicines were also included. A complete manual (and much more) is available online.  

While there are interesting findings regarding antibiotics used for respiratory infections, I’m going to limit my notes and comments to antiasthma medications.

Two drugs for asthma were included in the basket of 15 medicines that were represented in at least 80 percent of the surveys:

• Beclomethasone (0.05mg/dose) inhaler
• Salbutamol (0.1mg/dose) inhaler

However, specific data for beclomethasone was not included in the report, so I’m focusing on the results for salbutamol.

Availability – Low public and private sector availability

Overall, public sector availability of surveyed generics ranged from 29 to 54 percent across WHO regions.

Public section availability of salbutamol was very poor – only 29 percent (the lowest) overall. It ranged from 5 percent in Southeast Asia, 14 percent in Africa, 35 percent in Eastern Mediterranean, 42 percent in Europe, 48 percent in Western Pacific, to 88 percent in the Americas.

Private sector availability was a bit better overall (61 percent) – still the lowest of the target medications – with availability ranging from a low of 47 percent in Africa to a high of 79 in southeast Asia.

Price – Below the international reference price across most regions

Overall, private sector patients paid 9-25 times international reference prices for generic products and over 20 times international reference prices for originator products across WHO regions.

Surprisingly, however, the median price ratio for salbutamol inhalers was below the international reference price in all WHO regions except for the Americas; in a couple of regions (Africa, Southeast Asia) it was substantially lower.

Affordability – Not enough info to judge affordability of real-world asthma treatment

The report estimates affordability using the salary of the lowest-paid unskilled government worker to establish the number of day’s wages needed to purchase a course of treatment (30 day supply) for a variety of acute and chronic conditions (respiratory infection, diabetes, asthma and ulcer).

Unfortunately, the course of treatment for asthma only refers to a salbutamol inhaler; even though data on beclomethasone were collected, they are not included or reported (nor is any other anti-inflammatory).

Nevertheless, the authors report affordability for a month of inhaled salbutamol of 1.2-4.4 days in the private sector (originator brands) across regions, 0.6-5 days for private sector lowest priced generics; and 0.6-15 days for public sector lowest priced generics.

They note another shortcoming in the evaluation of affordability: That a substantial portion of the populations in many of these regions may earn less than the daily wage of the lowest-paid government worker. And they suggest that “further work is underway to identify alternative measures of affordability that could be included in the WHO/HAI methodology.”

The Indian setting

One other thing about the report that I found interesting. India – with its pricing regulations and vigorous domestic pharmaceutical industry (large number of generic manufacturers)  – appears to be have several lessons for efforts to improve the availability and affordability of medicines. In fact, the situation there is so unique that the manuscript reports the results from India separately.

For example, the availability of private sector generics was higher in India than in upper middle-income countries, while the median price ratios were much lower in India compared to other low income, lower-middle income and upper-middle income countries.

Moreover, median price differences between originator brands and lowest-priced generics in the private sector were also much lower in India (6% compared to over 300% in other low and lower-middle income countries).

Summary

With increasing demand for treatment of chronic respiratory disease in many low and lower-middle income countries, the value and timeliness of this report and methodology can’t be overstated. A more detailed analysis of typical asthma regimens – and some possible low-cost alternatives – should be at the center of global respiratory health efforts; improved public sector support for chronic respiratory disease medications is needed too.

As the authors write, “Increased emphasis should be placed on reducing the cost of these medicines in light of the high burden of non-communicable diseases. The affordability of chronic disease treatment is further constrained by the frequent need for more costly combination therapies and by the ongoing nature of treatment.”

News that El Salvador has recently become the first country to order from the Global Asthma Drug Facility hopefully indicates some progress, at last, “to increase availability, lower prices, and improve affordability of [asthma] medicine in all regions and at all levels of country development.”